JP2022551133A - 体温ロギングパッチを使用するシステムおよび方法 - Google Patents
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Abstract
Description
本願は、2019年10月7日出願の米国特許仮出願第62/911,850号、発明の名称“SYSTEM AND METHOD OF USING BODY TEMPERATURE LOGGING PATCH”、および2019年11月12日出願の米国特許仮出願第62/934,188号、発明の名称“SYSTEM AND METHOD OF USING BODY TEMPERATURE LOGGING PATCH”の優先権を主張するものであり、これらすべてはここで参照したことにより本明細書に組み込まれるものとする。
最近の癌治療には様々な免疫療法が含まれている。それらのうち、キメラ抗原受容体T細胞(CAR-T)療法は、患者から採取した自家T細胞にキメラ抗原受容体(CAR)遺伝子を発現させる操作を含む。CAR遺伝子は、患者の癌細胞の表面上の特別なタンパク質に結合するT細胞上の受容体の成長を誘発する。採取され、次いで操作された細胞は、試験管内で増殖され、その後、患者に再び注入される。いったん患者の体内に入ると、細胞はさらに対数的に増殖し続け、CAR受容体が標的とする患者の癌細胞を攻撃する。
本開示の第1の実施例によれば、方法は以下のステップを含む。すなわち、所定の収集期間中に患者から収集された温度データを、連続温度モニタから受信するステップと、将来の期間について予測温度データを出力するようにトレーニングされた機械学習システムに、受信した温度データを入力するステップと、発熱の指標について予測温度データを分析するステップと、分析の結果の通知を、患者のパーソナルデバイスおよび/または臨床医に送信するステップとを含む。
上述の記載を考慮すると、CRSは、その初期段階では治療可能であるが、特に進行度4まで進んでしまうと致命的なものとなるおそれがある。表1に示したように、CRSは初期段階では発熱を特徴とする。したがって、CRSの影響を受けやすい患者における発熱の早期検出を、CRS発症の識別に役立たせることができ、それによってCRSを適時に治療することができる。通例、温度監視に対する目下の看護標準は、患者の温度を4時間ごと、または1日に(すなわち24時間の期間につき)約6回記録することである。しかしながらこのような比較的低い頻度での温度チェックでは、CRS発症の早期兆候を見逃してしまう可能性が高い。
Claims (15)
- 所定の収集期間中に患者から収集された温度データを、連続温度モニタから受信するステップと、
将来の期間について予測温度データを出力するようにトレーニングされた機械学習システムに、受信した前記温度データを入力するステップと、
発熱の指標について前記予測温度データを分析するステップと、
前記分析の結果の通知を、前記患者のパーソナルデバイスおよび/または臨床医に送信するステップと、
を含む方法。 - 前記機械学習システムは、ネットワークを介して前記連続温度モニタおよび前記臨床医に遠隔接続されている、請求項1記載の方法。
- 前記患者は、キメラ抗原受容体T細胞(CAR-T)療法を受けているかまたは受けたことがあり、前記発熱はサイトカイン放出症候群に起因するものである、請求項1記載の方法。
- 前記機械学習システムを、サイトカイン放出症候群の発熱中に患者から収集された温度データを用いてトレーニングする、請求項1記載の方法。
- 当該方法はさらに、受信した前記温度データを前記機械学習システムに入力する前に、予め定められた閾値を下回る値を有する温度データポイントを補正するステップを含む、請求項1記載の方法。
- 発熱に関する前記予測温度データを分析するステップは、前記予測温度データの値を予め定められた閾値と比較するステップを含む、請求項1記載の方法。
- 発熱に関する前記予測温度データを分析するステップは、前記予測温度データの特性を予め定められた閾値と比較するステップを含み、前記特性は、
前記予測温度データの増加速度、または
予測温度データが予め定められた閾値よりも大きい期間、
を含む、
請求項1記載の方法。 - 前記収集期間は3時間であり、前記将来の期間は1時間である、請求項1記載の方法。
- 前記通知は前記予測温度データの時系列グラフを含む、請求項1記載の方法。
- 前記分析の結果が前記発熱を示しているならば、前記通知は、警告と、医療機関を受診するようにという患者向けの指示とを含む、請求項1記載の方法。
- 前記機械学習システムは、マルチステップ多層パーセプトロンネットワークを含む、請求項1記載の方法。
- 前記機械学習システムは、単変量マルチステップ畳み込みニューラルネットワークを含む、請求項1記載の方法。
- 前記機械学習システムは長短期記憶モデルを含む、請求項1記載の方法。
- 前記機械学習システムはシーケンス・トゥ・シーケンスモデルを含む、請求項1記載の方法。
- 前記温度データを受信すると実質的にリアルタイムに前記通知を送信する、請求項1記載の方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
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US201962911850P | 2019-10-07 | 2019-10-07 | |
US62/911,850 | 2019-10-07 | ||
US201962934188P | 2019-11-12 | 2019-11-12 | |
US62/934,188 | 2019-11-12 | ||
PCT/US2020/054476 WO2021071874A1 (en) | 2019-10-07 | 2020-10-07 | System and method of using body temperature logging patch |
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JP2022551133A true JP2022551133A (ja) | 2022-12-07 |
JP7459242B2 JP7459242B2 (ja) | 2024-04-01 |
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EP (1) | EP4041065A4 (ja) |
JP (1) | JP7459242B2 (ja) |
KR (1) | KR20220070532A (ja) |
CN (1) | CN114727764A (ja) |
AU (1) | AU2020362178B2 (ja) |
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US11224345B1 (en) * | 2020-08-06 | 2022-01-18 | Ideal Innovations Inc | Personal warning temperature (PWT) |
WO2023281281A1 (en) | 2021-07-08 | 2023-01-12 | 37 Clinical Limited | Fever prediction |
US20240006067A1 (en) * | 2022-06-29 | 2024-01-04 | Biosigns Pte. Ltd. | System by which patients receiving treatment and at risk for iatrogenic cytokine release syndrome are safely monitored |
WO2024076918A1 (en) * | 2022-10-03 | 2024-04-11 | Zoll Circulation, Inc. | Smart patient monitoring device for predicting patient temperature |
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